Eli Lily has officially announced, in collaboration with Incyte, new results that found the company’s baricitinib drug was able to achieve positive results when it came to treating adolescent patients (ages 12 to under 18) suffering from severe alopecia areata (AA).
According to certain reports, upon being administered oral baricitinib in 4 mg and 2 mg doses, patients experienced clinically meaningful improvements in hair regrowth on the scalp, eyebrows, and eyelashes at Week 36.
Before we dig any further, we ought to acknowledge that AA happens to be an immune system condition which causes patchy hair loss on the scalp, face, and at times, on other areas of the body that can progress over time. More on that would reveal how as estimated 40% of all patients with AA experience their first onset by 20 years of age.
In response, Eli Lily brings forth a therapeutic, which was recently put through a comprehensive study. This particular study, named as BRAVE-AA-PEDS, recruited a total of 257 patients, who were randomized to receive once-daily baricitinib 4 mg, baricitinib 2 mg, or placebo.
The primary endpoint of this study was a Severity of Alopecia Tool (SALT) score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. You see, at the start of the study, patients had an average of 89% scalp hair loss (near total hair loss), 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3), and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3).
“Early onset alopecia areata can be more severe, leading to extensive hair loss that frequently does not improve with topicals or corticosteroids often prescribed as first-line therapy,” said Brittany Craiglow, M.D., Adjunct Associate Professor of Dermatology, Yale School of Medicine. “These initial results are exciting because they demonstrate that baricitinib can provide significant hair regrowth for adolescents at 36 weeks, a promising early signal of baricitinib’s potential as an effective treatment for adolescents.”
Talk about the published results on a slightly deeper level, we begin from the fact that 60.0% of patients receiving baricitinib 4 mg, and 36.9% of patients receiving baricitinib 2 mg, saw at least a 50% improvement in their disease (measured by SALT score), as compared to 5.7% on placebo (p=0.001).
Next up, the study figured that nearly 42.4% of patients who received baricitinib 4 mg, and 27.4% of patients received baricitinib 2 mg, achieved 80% or more scalp hair coverage, compared to 4.5% on placebo (p=0.001).
Another detail worth a mention here is rooted in 36.5% of patients, who received baricitinib 4 mg, and 21.4% of patients who received baricitinib 2 mg, achieving 90% or more scalp hair coverage (SALT ≤10), compared to 2.3% on placebo (p=0.001).
Moving on, the study in question also discovered that 50.0% of patients receiving baricitinib 4 mg, and 24.1% of patients receiving baricitinib 2 mg, clocked significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline), as compared to 0% on placebo (p<0.01).
Finally, our last piece of highlight stems from how 42.9% of patients, who received baricitinib 4 mg achieved significant eyelash regrowth, and 25.5% received baricitinib 2 mg, ended up witnessing eyelash regrowth, as compared to 14.0% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg).
Among other things, we must mention that the most common treatment-emergent adverse events in BRAVE-AA-PEDS included acne, influenza, and upper respiratory tract infection. Furthermore, higher frequency of serious adverse events was seen in the placebo group compared to baricitinib group.
For the future, Lilly will present more data from the BRAVE-AA-PEDS study at scientific meetings later this year before submitting the results for peer-reviewed publication.
“With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families,” said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. “We are excited about these initial results, which show baricitinib can provide significant scalp hair regrowth in adolescents, potentially at an even faster rate compared to adults.”
